FDA Expedited Approvals of Expanded Cord Blood Products

As of this week, the following products manufactured from expanded cord blood have been granted expedited pathways to FDA approval.
Parent's Guide to Cord Blood Foundation published a review of expanded cord blood products in May 2018.

DateExpanded
Cord Blood
Product
ManufacturerIndicationFDA Expedited Path(s)
20180717NiCord®Gamida CellHSCT: Hematopoietic
Stem Cell Transplants
Breakthrough Therapy
Orphan Drug
20180806NLA101
Dilanubicel
Nohla TherapeuticsHSCT engraftment,
Neutropenia
Orphan Drug
Fast Track
20180823Pneumostem®MedipostBronchopulmonary DysplasiaOrphan Drug
Fast Track
20190423ECT-001ExCellTheraHematologic
Malignancies
Regenerative Medicine Advanced Therapy (RMAT)
20190904MGTA-456Magenta
Therapeutics
Inherited Metabolic DisordersRegenerative Medicine Advanced Therapy (RMAT)
These comments are submitted by website readers and are not endorsed by CellTrials.org, which is a project of Parent's Guide to Cord Blood Foundation. We screen the comments to keep out SPAM but we cannot review each one for accuracy.